NHP/FI Building Success Conference A Reality Check: Overcoming the challenge of changing regulations Brenna Boonstra Regulatory Affairs Manager, NHP Consulting Inc.
Current state of the dynamic regulations Source: https://www.chfa.ca/files/regulatory_files/CHFA_Tradeshows/CHFA_East_Regulatory_Forum_SFCR.pdf
Regulatory Compliance, in all cases • Responsibilities of the manufacturer/importer: – Safety/quality of product – Accurate positioning in the marketplace – Conform with applicable regulations – All food/supplement businesses should have awareness
Product Classification • Classification of a product drives regulatory requirements (how and when you can sell) • Products can fit in more than one category Especially true for functional foods (“food -like NHPs ”) • Novel food - Compliant food • Non-compliant food - Supplemented food • Natural health product • Food can be medicine, but the regulations differ. Health Canada guidance: http://www.hc-sc.gc.ca/dhp- mps/prodnatur/legislation/docs/food-nhp-aliments-psn-guide-eng.php
The first step in classification: (1) Product Composition – All ingredients are considered – Food ingredients – Non-food ingredients – Added amino acids, vitamins, minerals – Novel ingredients – Additives
Permitted Food Additives Health Canada reference: http://www.hc-sc.gc.ca/fn-an/securit/addit/list/index-eng.php
Classification: (2) Product representation • Positioning – Health (therapeutic) claims? – Nutrition, satisfying hunger, thirst, desire for flavour? • Directions of use • Point(s) of sale
Classification: (3) Product format • Food-Like format Food • Beverages, candies, bars • Pharmaceutical/cosmetic format Not a food • Capsules, tablets, creams, lotions • Powders, liquids Ambiguous
Classification: (4) Public perception and history of use • Historical pattern of use as food or therapeutic product • Ready to drink liquids above/below 90 mL packages
Classification: (5) Owner preference and flexibility • Sometimes more than one regulatory path is available • Flexibility in formulation, marketing, packaging offers choice • Knowledge of regulations allows conscious choices in composition, representation, brand name, and format of your products that can affect how your products are regulated
Example: Coffee + Reishi Mushroom • Ingredients -Coffee bean -Reishi mushroom -Acesulfame-K • Classification – Composition – History of use – Format – Representation – Owner preference
The categories: Compliant Food • All acceptable food ingredients – Minimal processing – History of safe use as a food – Serve food purposes • Nourishment/Nutrition • Hydration • Satisfy hunger/thirst • Desire for taste, texture, flavour • All permitted Food Additives
Apply: Compliant Food • Simplest from a regulatory perspective • No pre-market approval required • No facility registration required, though this will be changing • Prescriptive composition • Limited claims – Nutrient-Function -Nutrient-Content – General Health -Function – Disease risk reduction -Limited therapeutic
Regulations and Guidance: Compliant Foods Canadian Food Inspection Agency • http://www.inspection.gc.ca /about-the-cfia/acts-and-regulations/list-of-acts-and-regulations/eng/1419029096537/1419029097256 Health Canada • http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/acts-reg-lois-eng.php Food and Drugs Act • Food and Drug Regulations (FDR) • Safe Food For Canadians Act (SFCA) • Consumer Packaging and Labelling Act • Food Labelling Guidance: • http://www.inspection.gc.ca/food/labelling/food-labelling-for- industry/eng/1383607266489/1383607344939 Nutrient Function Claims • http://inspection.gc.ca/food/labelling/food-labelling-for-industry/health- claims/eng/1392834838383/1392834887794?chap=8 Therapeutic Claims http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/index-eng.php •
The categories: Non-compliant Food • Some aspect outside the FDR – New ingredient – Added vitamins, minerals, amino acids – New additive • Supplemented foods often fall into this category • “Non - compliant” food doesn’t mean the product can never be sold, but additional regulatory steps are required
Apply: Non-compliant Food • Pre-market steps required • Temporary Marketing Authorization Letter (TMAL) • Novel food submission • Food additive submission • Limited claims • Prescriptive composition • Can be reformulated into compliant foods to facilitate immediate market access
Regulations and Guidance: Non-Compliant Foods Canadian Food Inspection Agency • http://www.inspection.gc.ca /about-the-cfia/acts-and-regulations/list-of-acts-and- regulations/eng/1419029096537/1419029097256 Health Canada • http://www.hc-sc.gc.ca/ahc-asc/legislation/acts-reg-lois/acts-reg-lois-eng.php Food and Drugs Act • Food and Drug Regulations (FDR) • Safe Food For Canadians Act (SFCA) • Consumer Packaging and Labelling Act • Food Labelling Guidance: • http://www.inspection.gc.ca/food/labelling/food-labelling-for- industry/eng/1383607266489/1383607344939 TMAL Guidance: • http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/food-market-author-marche-aliment-eng.php Nutrient Function Claims • http://inspection.gc.ca/food/labelling/food-labelling-for-industry/health- claims/eng/1392834838383/1392834887794?chap=8 Therapeutic Claims http://www.hc-sc.gc.ca/fn-an/label-etiquet/claims-reclam/assess-evalu/index- • eng.php
Example: Super Cranberry • Classification – Composition – Representation – Format – History of use – Owner preference
The categories: Natural Health Product • Pharmaceutical format • Therapeutic claims • Non-food ingredients • Specific directions of use • Risk information • Ingredients recognized by NNHPD
Natural Health Products Ingredients Database http://webprod.hc-sc.gc.ca/nhpid-bdipsn/search-rechercheReq.do
Apply: Natural Health Product • Pre-market approval required – Claims – Formula – Directions of use • Site licensing – Facility registration – Finished product (quality) testing • Regulatory Tool: Monographs
http://webprod.hc-sc.gc.ca/nhpid-bdipsn/monosReq.d%3Flang=eng
Regulations and Guidance: Natural Health Products Natural and Non-Prescription Health Products Directorate • (NNHPD) – Health Canada http://www.hc-sc.gc.ca/dhp-mps/prodnatur/about-apropos/index-eng.php Natural Health Product Regulations (NHPR) • Food and Drugs Act • Food and Drug Regulations (FDR) • Safe Food For Canadians Act (SFCA) • Consumer Packaging and Labelling Act • NHP Labelling Requirements Checklist • http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/label-list-etiquet-eng.php Quality of Natural Health Products Guide • http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/eq-paq-eng.php Site Licensing • http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php
Example: Energy Drink Ingredients: • Carbonated water – Whey protein – Acesulfame potassium – FD&C Red #40 – Green Tea – Vitamin B12 – Taurine – Caffeine – Classification • Composition – Representation – Format – History of use – Owner preference –
Contact: Brenna Boonstra brenna@nhpconsulting.ca
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